Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Carcinoma, Hepatocellular

Carcinoma, Renal Cell

Liver Neoplasms

Head and Neck Neoplasms

Sarcoma

Kidney Neoplasms

Colonic Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Liver Diseases

Pancreatic Cancer

Renal Cell Carcinoma

Soft Tissue Sarcoma

Herbal and Botanical

All Drugs and Chemicals

Cola

Patient receives assigned dose level:

Dose Level 1 = 400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 2 = 400 milligrams (mg) of pazopanib and ixabepilone 40 mg/m2. Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 4 = 800 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.

Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.

Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.

Pazopanib

Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle

Ixabepilone

Arkaduisz Z Dudek, MD

This is a Phase I study; dose escalating the combination of pazopanib when taken daily and ixabepilone when administered on day 1 of a 3 week treatment course.

Treatment with ixabepilone will be given at an assigned dose as a 3 hour intravenous infusion on day 1 of a 21 day cycle. Treatment with pazopanib will be given at an assigned dose by mouth once a day, beginning on day 1 and continuing daily. Disease assessment will be done every 2 cycles (6 weeks) with treatment continuing until disease progression, unacceptable toxicity or patient refusal.

Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

Phase I Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

The optimal tolerated regimen is the regimen where ≤ 1 out of 6 patients experiences a dose limiting toxicity (DLT). DLT is defined as one of the following events occurring during cycle 1: grade 4 or greater treatment related hematologic toxicity for \> 7 days during the first cycle (21 days) of therapy; grade 3 or greater treatment related clinical non-hematological toxicity (excluding ≥ grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis) during the first cycle (21 days) of therapy; or a delay of cycle 2 treatment start by more than 2 weeks due to incomplete hematologic recovery (ANC \> 1.5 x 109/L or platelets 100 x 109/L) or unresolved treatment related grade 3 or greater non-hematologic toxicity.

A DLT was defined as one of the following events occurring during cycle 1: (1) grade 4 or greater treatment-related hematologic toxicity for \>7 days; (2) grade 3 or greater treatment-related clinical non-hematologic toxicity (excluding \>/= grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis); or (3) delay of starting cycle 2 treatment by \>2 weeks due to incomplete hematologic recovery (absolute neutrophil count \> 1.5 X 10\^9/L or platelets \>100 X 10\^9/L) or unresolved treatment-related grade 3 or greater non-hematologic toxicity. Adverse events were classified according to Common Terminology Criteria for Adverse Events V 3.0 (CTCAE).

Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.

GlaxoSmithKline

Masonic Cancer Center, University of Minnesota

Dose Level 1

Dose Level 2

Pazopanib 600mg - Ixabepilone 32 mg/m2 Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.

Dose Level 3

Dose Level 4

Arm 1: Dose Level 1

Arm 1: Dose Level 2

Arm 1: Dose Level 3

Arm 1: Dose Level 4

Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.

Arm 2

Total

Age, Categorical

Sex: Female, Male

Dr. Arkadiusz Dudek

All participants who received at least one cycle of one of the following 4 dose levels: Dose Level 1: Pazopanib 400mg - Ixabepilone 32mg/m2; Dose Level 2: Pazopanib 400mg - Ixabepilone 40mg/m2; Dose Level 3: Pazopanib 600mg - Ixabepilone 32 mg/m2; or Dose Level 4: Pazopanib 800mg - Ixabepilone 32 mg//m2.

All Arm 1 Participants

The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination

400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.

400 milligrams (mg) of Pazopanib and Ixabepilone 40 mg/m2

600 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2

800 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2

6400 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2

Arm 2: Dose Level 3

6 participants were included at Dose Level 1 to confirm safety after escalation to Dose level 2, but are grouped with the original 3 participants enrolled at Dose Level 1.

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)

Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.

Spots Global Cancer Trial Database for Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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